Asymptomatic Biomarker-Positive Population
Preclinical Alzheimer's biomarker-positive adults form the trial's target pool, placeholder.
- 60–80 yrs: Target age range (Placeholder eligibility range)
- Normal / unimpaired: Cognitive status (Placeholder inclusion note)
- ~20–30%: Biomarker prevalence (Placeholder population estimate)
- Registries & cohorts: Recruitment source (Placeholder sourcing note)
Defining the preclinical target population
Placeholder: rationale for enrolling asymptomatic biomarker-positive adults.
Blood Biomarker Pre-Screening Funnel
A blood-based assay filters the population before costlier confirmatory testing, placeholder.
- Plasma p-tau / Aβ: Assay type (Placeholder assay note)
- ~20%: Pre-screen positivity (Placeholder rate estimate)
- Low relative to PET: Cost per test (Placeholder cost note)
- Days: Turnaround (Placeholder turnaround estimate)
Blood test as a funnel narrowing step
Placeholder: blood biomarker pre-screening reduces need for confirmatory scans.
Confirmatory PET/CSF Testing
Amyloid PET or CSF testing confirms pre-screen-positive candidates, placeholder.
- PET or CSF: Confirmation method (Placeholder method note)
- ~60–70%: Confirmatory positivity (Placeholder concordance figure)
- High relative to blood test: Cost (Placeholder cost note)
- Moderate–high: Participant burden (Placeholder burden note)
Confirmatory testing accuracy and burden
Placeholder: PET/CSF confirmatory step and its accuracy trade-offs.
Trial Enrollment Eligibility Criteria
Confirmed-positive candidates are checked against remaining eligibility criteria, placeholder.
- Normal range scores: Cognitive criteria (Placeholder criteria note)
- Defined exclusions: Comorbidity limits (Placeholder exclusion note)
- Informed consent: Consent process (Placeholder consent note)
- ~1 in 15 screened: Final enroll rate (Placeholder funnel figure)
Final eligibility gate before randomization
Placeholder: eligibility criteria applied before final randomization.
Prevention Trial Cognitive Endpoint Tracking
Enrolled participants are followed on cognitive and biomarker endpoints, placeholder.
- Cognitive composite: Primary endpoint (Placeholder endpoint note)
- Multi-year: Follow-up duration (Placeholder duration estimate)
- Biomarker trajectories: Secondary endpoints (Placeholder secondary note)
- Periodic assessments: Visit cadence (Placeholder cadence note)
Tracking cognitive trajectories over time
Placeholder: long-term cognitive endpoint tracking design in prevention trials.
Placeholder key insight: early biomarker enrollment enables prevention-focused endpoints.